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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 409 drug applications between 24 August 2025 and 30 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 73 drug names.

2025/08/24 – 2025/08/30

Period
2025/08/24 to 2025/08/30, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
409
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
95

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

409filings, 105 of them generic

By application type

Application typeFilings
Supplement185
Generic105
New drug70
Import37
Unspecified9
Import re-registration3

By drug type

Drug typeFilings
Chemical drug276
TCM69
Therapeutic biologic55
Biologic7
Unspecified1
Prophylactic biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sufentanil Citrate Injection410
2瑞维那新吸入溶液 · No verified English name3353
3Apalutamide Tablets3318
4Sacubitril Valsartan Sodium Tablets3170
5Ambroxol Hydrochloride Injection319
6Polidocanol Injection3123
7甘油磷酸钠注射液 · No verified English name227
8Glucosamine Sulfate Capsules2251
9Iguratimod Tablets2223
10Mupirocin Ointment2230

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

229 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1720
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1080
3Gui Lin Hua Run Tian He Pharma Co., Ltd. romanized770
4Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized760
5AstraZeneca AB520
6Novo Nordisk A/S510
7Takeda Canada Inc510
8Terumo Corporation Kofu Factory510
9Qilu Pharmaceutical Co., Ltd.510
10Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized440

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

139 this week

AcceptedDrugApplicants
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500115 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500114 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500113 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500112 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500111 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 1 [225Ac]Ac-FL-020注射液 · No verified English nameJXHL2500250 Full-Life Technologies GmbH; Shanghai Full-life Technologies Co. Ltd.
2025/08/30Import · Class 1 [111In]In-FL-020注射液 · No verified English nameJXHL2500249 Full-Life Technologies GmbH; Shanghai Full-life Technologies Co. Ltd.
2025/08/30Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500248 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/30Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500247 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/30Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500246 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/30Generic · Class 3 Metformin Hydrochloride Oral SolutionCYHS2503201 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/08/30Generic · Class 3 Metformin Hydrochloride Oral SolutionCYHS2503200 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/08/30Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2503199 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/08/30Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2503195 Wuhan Hua Er Bio Technology Co., Ltd. romanized; Wuhan Qi Rui Pharma Co., Ltd. romanized
2025/08/30Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2503194 Wuhan Hua Er Bio Technology Co., Ltd. romanized; Wuhan Qi Rui Pharma Co., Ltd. romanized
2025/08/30Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503187 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2025/08/30Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503186 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2025/08/30Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503185 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2025/08/30Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503184 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2025/08/30New drug · Class 1 注射用ZG006 · No verified English nameCXSL2500753 Name not romanized; Name not romanized
2025/08/30New drug · Class 1 注射用戈氏梭菌芽孢冻干粉 · No verified English nameCXSL2500752 Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized
2025/08/30New drug · Class 1 9MW3811注射液 · No verified English nameCXSL2500751 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2025/08/30New drug · Class 1 SCTC21C注射液 · No verified English nameCXSL2500750 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/08/30New drug · Class 2.2 吡仑帕奈口溶膜 · No verified English nameCXHS2500105 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2025/08/30New drug · Class 2.2 吡仑帕奈口溶膜 · No verified English nameCXHS2500104 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2025/08/30New drug · Class 1 HH101785片 · No verified English nameCXHL2500933 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2025/08/30New drug · Class 1 HH101785片 · No verified English nameCXHL2500932 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2025/08/30New drug · Class 2.4 硫酸艾玛昔替尼片 · No verified English nameCXHL2500931 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/30New drug · Class 2.2 P-0264直服颗粒 · No verified English nameCXHL2500930 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2025/08/30New drug · Class 2.1; 2.4; 2.2 SHR0302碱凝胶 · No verified English nameCXHL2500929 Rui Shi Biopharmaceuticals Co., Ltd. romanized

109 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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